A Prospective, Randomised Long-term Follow-up of Operative Versus Non-operative Treatment of Gr. 3 Acromioclavicular Dislocation

NCT00840593 | Completed

• 1 other identifier: KUH5203037
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare the long-term clinical and radiological results of operative and conservative treatment of Tossy type 3 acromio-clavicular dislocation.

Conditions

Acromioclavicular Joint; Dislocation; Surgical Procedures, Operative

Keywords

Acromioclavicular Joint; Dislocation; Trials, Randomized Clinical; Surgical Procedures, Operative

Outcome Measures

Primary Outcomes (1)

• Presence of delayed surgical procedure to treat the AC joint dislocation pathology

  from 18 to 20 years

Secondary Outcomes (26)

• Grading of the AC dislocation using Rockwood classification (3-6)

  18-20 years

• AC joint width in the middle of the joint (mm)

  18-20 years

• Distance between proc. coracoideus and clavicle (coracoclavicular interspace) in Zanca projection, compared to non-injured side(mm)

  18-20 years

• Osteolysis of clavicle (none, mild, moderate, severe) for follow-up radiographs

  18-20 years

• Presence of calcification of CC ligaments (yes/no)

  18-20 years

Study Arms (2)

1. Non-surgical group

ACTIVE COMPARATOR

The non-surgical treatment consisted of immobilisation of the injured AC-joint in a Kenny-Howard-type splint for four weeks. The patient was encouraged in mobilisation of the elbow several times per day and the mobilisation of the shoulder with pendulum type movements were initiated four weeks after the injury. Active mobilisation of the shoulder was allowed six weeks after the injury.

Procedure: Non-surgical group

2 Surgical group

ACTIVE COMPARATOR

The surgical treatment was accomplished within two days after the injury, and it consisted of an open reduction and fixation of the AC joint with two smooth Kirschner wires (2 mm in diameter) across the AC-joint. The K-wires were bent at the proximal ends, with suturing of the superior AC ligament. The position of Kirschner wires was confirmed during the operation using C-arm transillumination. The articular disc of AC joint was removed if it was damaged. Postoperative care consisted of immobilisation of the AC joint in a sling, (Polysling, body band) for four weeks and the mobilisation of the shoulder started four to six weeks later in a similar manner as in the non-operative group.

Procedure: Surgical group

Interventions

Non-surgical group PROCEDURE

The non-surgical treatment consisted of immobilisation of the injured AC-joint in a Kenny-Howard-type splint for four weeks. The patient was encouraged in mobilisation of the elbow several times per day and the mobilisation of the shoulder with pendulum type movements were initiated four weeks after the injury. Active mobilisation of the shoulder was allowed six weeks after the injury.

1. Non-surgical group

Surgical group PROCEDURE

The surgical treatment was accomplished within two days after the injury, and it consisted of an open reduction and fixation of the AC joint with two smooth Kirschner wires (2 mm in diameter) across the AC-joint. The K-wires were bent at the proximal ends, with suturing of the superior AC ligament. The position of Kirschner wires was confirmed during the operation using C-arm transillumination. The articular disc of AC joint was removed if it was damaged. Postoperative care consisted of immobilisation of the AC joint in a sling, (Polysling, body band) for four weeks and the mobilisation of the shoulder started four to six weeks later in a similar manner as in the non-operative group.

2 Surgical group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient with Tossy grade 3 AC-dislocation was recruited between the years 1989 and 1991 at Kuopio University Hospital for a randomized controlled study
• A written informed consent.

You may not qualify if:

• Not written informed consent

Sponsors & Collaborators

• Kuopio University Hospital: lead

Study Sites (1)

Kuopio University Hospital

Kuopio, Kuopio, 70211, Finland

Location

MeSH Terms

Conditions

Joint Dislocations

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: February 9, 2009
• First Posted: February 10, 2009
• Study Start: February 1, 2009
• Primary Completion: June 1, 2009
• Study Completion: August 1, 2009
• Last Updated: December 8, 2011

Record last verified: 2011-12

Locations

FI (1)